Clinical trials: Systemic Sclerosis (SSc)
Systemic Sclerosis
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
- Trial name
- Breakfree-SSc (NCT07335562)
- Testing
- BMS-986353, Fludarabine, Cyclophosphamide
- Where
- 56 sites in United States, Belgium and 8 more
- Volunteers
- 92 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS)
- Trial name
- NCT05000216
- Testing
- Moderna mRNA-1273, BNT162b2, Ad26.COV2.S
- Where
- 29 sites in United States
- Volunteers
- 258 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Systemic Lupus Erythematosus, Systemic Sclerosis
Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)
The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors)…
- Trial name
- NCT00684255
- Testing
- Reduced Intensity Allogeneic Transplant, Fludarabine, Busulfan
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- New York Medical College
Autoimmune Diseases, SLE - Systemic Lupus Erythematosus
RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases
This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19/BCMA dual-targeting chimeric antigen receptor T-cell…
- Conditions
- Autoimmune Diseases, SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies
- Trial name
- NCT07674147
- Testing
- RD06-05 CART Cell Infusion
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Systemic Sclerosis, Diffuse Sclerosis Systemic
Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis
The purpose of this study is to determine whether a regimen of high-dose immunoablative therapy will demonstrate safety that is consistent or improved with other published regimens in SSc patients, while maintaining a treatment…
- Conditions
- Systemic Sclerosis, Diffuse Sclerosis Systemic, Interstitial Lung Disease, Pulmonary Hypertension
- Trial name
- SSc (NCT03630211)
- Testing
- Cyclophosphamide, Mesna, Rituximab
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Paul Szabolcs
Refractory Lupus Nephritis, Systemic Sclerosis
CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH
This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), primary Sjogren syndrome combined with pulmonary artery hypertension…
- Conditions
- Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension, Other Autoimmune Diseases (AID)
- Trial name
- NCT06947460
- Testing
- CD19-BCMA CAR-T cells infusion
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Beijing GoBroad Hospital
According to the IRB Approval
NVC Test in Order to Assess Pathological Changes in Family Members of Patient Diagnosed With SSc
Systemic sclerosis (SSc) is multisystem autoimmune disease of unknown etiology. It's characterized by activation of immune system, microvascular changes and intimal proliferation.
- Trial name
- SSc NVC (NCT02795221)
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Meir Medical Center
Autoimmune Diseases, Systemic Lupus Erthematosus (SLE)
CD19/BCMA UCAR-T for B Cell-Related Autoimmune Disease
This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erthematosus (SLE), Multi-Drug Resistant Nephrotic Syndrome, IgA Nephropathy (IgAN)
- Trial name
- NCT07586267
- Testing
- QT-219CX
- Where
- China
- Volunteers
- 15 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA)
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune…
- Conditions
- Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Systemic Lupus Erythematosus (SLE), Juvenile Systemic Lupus Erythematosus
- Trial name
- BTNDV-ARD (NCT07087912)
- Testing
- Dengue 1,2,3,4 (attenuated) vaccine
- Where
- 2 sites in Brazil
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Systememic Lupus Erythematosus, Systemic Sclerosis (SSc)
Investigation of Type I Interferon Excess in Patients With Systemic Autoimmune Diseases and Genetic Type I Interferonopathies
Systemic autoimmune diseases associated with type I interferon (IFN-I) dysregulation, such as systemic lupus erythematosus, systemic sclerosis, myositis, and mixed or undifferentiated connective tissue diseases, and genetic type…
- Conditions
- Systememic Lupus Erythematosus, Systemic Sclerosis (SSc), Inflammatory Myopathies, Connective Tissue Diseases
- Trial name
- SAFRAN (NCT07837986)
- Testing
- biological samples
- Where
- 3 sites in France
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis
Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases
This is an investigator-initiated trial to evaluate the efficacy and safety of BCMA/CD70-targeted CAR-T in the treatment of refractory pediatric rheumatic diseases.
- Conditions
- Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis, Systemic Sclerosis (SSc), Primary Sjogren's Syndrome
- Trial name
- NCT07184450
- Testing
- BCMA/CD70-targetd CAR-T
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Refractory Lupus Nephritis, Systemic Sclerosis
Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH.
This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension…
- Conditions
- Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension
- Trial name
- NCT06947473
- Testing
- umbilical cord blood CD19-BCMA CAR-T cells infusion
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Beijing GoBroad Hospital
Lung Diseases, Interstitial
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients…
- Trial name
- NCT04325217
- Testing
- Nintedanib
- Where
- Japan
- Volunteers
- 586 people
- Sponsor
- Boehringer Ingelheim
Systemic Sclerosis (SSc), Scleroderma
Patients Diagnosed With Scleroderma: Physical Performance and Functionality
Physical functionality and performance are important for individuals diagnosed with scleroderma. There is a need to address children and adults diagnosed with scleroderma comprehensively and to evaluate them on a biopsychosocial…
- Conditions
- Systemic Sclerosis (SSc), Scleroderma, Scleroderma (Limited and Diffuse), Scleroderma, Localized
- Trial name
- NCT07183072
- Testing
- Questionnaire and functionality application for child and adult scleroderma patients
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Hacettepe University
Systemic Sclerosis (SSc), GERD (Gastroesophageal Reflux Disease)
PPI Refractory - GERD Mechanisms in Systemic Sclerosis
The goal of this observational study is to learn about the mechanisms of gastroesophageal reflux disease (GERD) in patients with systemic sclerosis (SSc) who continue to experience reflux symptoms despite treatment with proton…
- Trial name
- NCT07022912
- Testing
- educational healthcare intervention, Objective assessment of GI motility, Evaluation of GERD severity
- Volunteers
- 147 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Systemic Sclerosis (SSc), Scleroderma
Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance
It is recommended to focus on the physical functionality, chewing, and swallowing performance of individuals diagnosed with scleroderma.
- Conditions
- Systemic Sclerosis (SSc), Scleroderma, Scleroderma (Limited and Diffuse), Scleroderma, Localized
- Trial name
- NCT07182981
- Testing
- Questionnaire application for child and adult scleroderma patients
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Hacettepe University
Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE), Dermatomyositis (DM), Systemic Sclerosis (SSc)
- Trial name
- NCT07729995
- Testing
- LMY-922
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Luminary Therapeutics
Systemic Sclerosis, Raynaud Phenomenon
Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot
The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions.
- Trial name
- NCT06291142
- Testing
- Observation - Nailfold capillaroscopy
- Where
- United Kingdom
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- University of Manchester
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
Autoimmune Diseases, Systemic Lupus Erthematosus (SLE)
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erthematosus (SLE), Multi-Drug Resistant Nephrotic Syndrome, IgA Nephropathy (IgAN)
- Trial name
- NCT07305116
- Testing
- UCAR T-cell
- Where
- China
- Volunteers
- 15 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine